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The Study Coordinators Organization for Research & Education (SCORE) recently held its 8th annual Half-Day Seminar. This year, the seminar included lectures on self-determination theory, standard operating procedures, and mindful practice, and also focused on root cause analysis, a method of reviewing adverse events that occur in clinical research in order to prevent recurrence.

SCORE, which is part of the Clinical and Translational Science Institute, provides support and networking opportunities for research coordinators and staff across the University of Rochester. With recent changes in Food and Drug Administration guidelines for investigation of adverse events in clinical trials, some of the burden of root cause analysis has fallen to study coordinators and research nurses.

That is why the Seminar Planning Committee, according to Nancy Needler, Manager, CTSI Research Coordinator Program decided to include a hands-on and “minds-on” root cause analysis practice in breakout sessions this year – a first for the SCORE Half-Day Seminar.

The hands-on practice was kicked off with a lecture on root cause analysis by Michael Leonard M.D. M.S., associate professor of Pediatrics and associate chief quality officer for UR Medicine. During his lecture, Leonard and a group of actors introduced a hypothetical scenario of an adverse event in clinical research. In the scenario, a teenaged participant in a clinical trial for a depression medication was sent to the emergency department after overdosing on the study drug.

According to Needler, key information was purposefully left out of the scenario introduction, “because you never have all of the information from an event in normal life situations.”

Seminar participants had the opportunity to gather more information by asking the actors questions prior to breaking into groups for discussions with trained facilitators. The seminar participants divided into six groups to review the facts and find areas or policies that could be changed to prevent this adverse event from happening again.

“What I thought was wonderful from all of the teams,” says Needler, “was that none said ‘it was so-and-so’s fault’. They all examined the process; not the person.”

That is key in root cause analysis. The goal is to identify the sources of error in a systematic process and to develop approaches that address the root of the issue. The seminar’s scenario reflects the reality that research teams plan and manage study activities with the utmost focus on ensuring participant safety and maintaining data integrity.

The presentation that followed the root cause analysis activity was an orientation to the development of Standard Operating Procedures (SOPs), which are a set detailed instructions for each process used in a clinical study. Root cause analysis often leads to development or modification of SOPs in order to prevent future adverse effects or breaches of protocol.

Closing the Half-Day, attendees participated in a mindful exercise guided by Ronald Epstein MD, professor of Family Medicine, Psychiatry and Oncology at URMC. Attendees were introduced to the concepts of mindfulness, to promote resilience and well-being in the workplace.

The seminar was well-attended with 123 participants from 9 institutions, with over 30 University of Rochester departments represented.

The CTSI, in partnership with the Department of Public Health Sciences, is rolling out a new advanced certificate in regulatory science for graduate students, postdocs, and researchers from a broad range of fields. The program is just one of several efforts by the CTSI to advance regulatory science and promote student and trainee interest in learning how new drugs and devices are developed and ultimately reviewed by the Food and Drug Administration (FDA).

The NYS-approved certificate, which is a graduate credential, requires 6 courses (totaling 13 credits) covering experimental therapeutics, medical product innovation, ethics, biostatistics, FDA regulatory process, intellectual property, and science, technology and health policy. Students will also obtain at least 3 additional credits in an area of their choice, including options such as pharmacology, epidemiology, clinical trials, drug discovery, or scientific communication.

Beyond the course work, the certificate program offers mentorship and assistance in finding internships and shadowing experiences for regulatory science careers. Additionally, certificate students will participate in the annual “America’s Got Regulatory Science Talent” competition. Each year, the winner of the competition is given the opportunity to present their proposal to scientists and leaders at the FDA.

According to Scott Steele, Ph.D., associate professor of Public Health Sciences and program director for the certificate, “that exposure can give students a unique opportunity to engage leaders in this field and an advantage in identifying career paths – especially in industry or government”.

Steele believes the new regulatory science certificate program can help students with a broad range of career goals. Understanding the opportunities and challenges with medical product development and the FDA regulatory process is extremely valuable whether students plan to stay in academia or branch out into industry, government or other sectors. This could include careers in research, policy, regulatory review, communications, program management and law.

Ultimately, the goal of regulatory science is to make the process of developing and approving new drugs and medical devices more efficient and ensuring that new, life-improving therapies can be properly and thoroughly evaluated as quickly as possible. Programs like the CTSI’s regulatory science certificate help by training scientists in the science, regulatory and policy issues involved in medical product development, creating a pipeline to the FDA, industry and other sectors. This helps improve the efficiency and effectiveness of the translational research process by reducing the “ramp up time” for professionals in industry, academia and FDA and creating a scientifically trained workforce that is proficient in the science and policy issues that underlay the medical product development and approval process.

The certificate program applications are currently being processed for Spring 2017 but students, post-doctoral fellows, researchers and faculty can begin registering for required coursework this fall. The fall registration period for matriculated students at the University of Rochester School of Medicine and Dentistry opens July 1.

For more information and a full list of certificate requirements, click here.

The biomedical sciences have struggled with diversity for a long time. Research shows that many groups who are under-represented in the general population, are even further under-represented in the biomedical science workforce. In fact, one study found that black scientists were less likely to receive NIH funding than their white peers who had similar training experiences, publication records and educational backgrounds.

To combat this, the NIH developed a Diversity Program Consortium that administers the National Research Mentoring Network (NRMN). The network consists of biomedical professionals and institutions that offer mentorship and professional development to mentors and trainees from under-represented racial and ethnic groups, those with disabilities or who come from disadvantaged backgrounds, and those who identify as lesbian, gay, bisexual, or transgender (LGBT) in the biomedical, behavioral, clinical, and social sciences.

Vivian Lewis M.D., vice provost for Faculty Development & Diversity and professor of Obstetrics and Gynecology at URMC, knows that culturally responsive mentoring is key to the success of any researcher. But she also knows that “just being a good researcher doesn’t make you a good mentor automatically. Here at University of Rochester we’ve had a lot of experience training mentors.”

In fact, Lewis leads the UR Mentors program that offers support and training to faculty across the university, including those in biomedical research, on how to be an effective mentor. One of the program’s major initiatives is to discuss the role of diversity and bias in the mentor-protégé relationship and understand the implications. Through the program, faculty gain confidence, knowledge, and skills to help them give their protégés the best leg up.

URMC also collaborates with Xavier University of Louisiana, a historically black college that is a NRMN academic partner and is funded by NRMN’s sister program, Building Infrastructure Leading to Diversity (BUILD). Many of Xavier’s pre-medical and pharmacy students have trained at University of Rochester School of Medicine and Dentistry over the years, but fewer biomedical research students have taken advantage of that partnership. Lewis hopes to recruit more under-represented students to come to URMC for mentored research experiences and to forge more faculty research collaborations through the NRMN partnership with Xavier.

John Cullen, PhD., director of Diversity and Inclusion at the CTSI and coordinator of Outreach in the Susan B. Anthony Center at the University of Rochester Medical Center, recently signed up to be a NRMN mentor and encourages both trainees and faculty to join the network. He cautions, “though the NRMN website primarily focuses on mentorship, it is extremely important for under-represented trainees to sign up as mentees. Anyone from undergraduates up through junior faculty can join as a mentee.”

A reporter from the Rochester Business Journal recently caught up with CTSI co-director Karl Kieburtz, M.D., M.P.H., to talk about what the CTSI has been up to in the past 10 years.

The CTSI’s new focus on bioinformatics – using digital technology to collect and analyze massive amounts of data – was the major focus of the article. Over the past ten years, the CTSI researchers have kept pace with the boom in new technologies like FitBits and smartphones, and social media sites like Facebook and Twitter by using these technologies as research tools. Several research project in the Center for Human Experimental Therapeutics, which is tightly integrated with the CTSI, utilize these technologies to track aspects of physical and psychological health of individual patients or entire populations.

Recognizing the opportunity and burden presented by rapidly collect enormous amounts of data, the CTSI has forged new partnerships with bioinformatics groups across the University of Rochester, including the Goergen Institute for Data Science. Providing easily accessible bioinformatics resources to help researchers perform informatics-related projects is one of the CTSI’s new major aims.

Kieburtz, who is also the senior associate dean of Clinical Research and Robert J. Joynt Professor of Neurology at the University of Rochester Medical Center, also highlighted the recent change in the CTSI’s administrative structure – doing away with the typical hierarchy with a single administrator at the top in favor of a three equal partners directing the institute. As Kieburtz pointed out, he and his two co-directors, Martin Zand, M.D., professor of Nephrology and Public Health Sciences at URMC, and Nancy Bennett, M.D., director of the Center for Community Health and professor of Medicine and Public Health Sciences at URMC, all have different areas of expertise. Each brings something special to the table, fostering the spirit of innovation and collaboration that is endemic to the CTSI.

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Batten diseases are rare genetic disorders that affect 2 to 4 of every 100,000 infants born in the U.S. Genetic mutations disrupt the function of the nervous system causing vision loss and epilepsy starting between ages 5 and 10 and ultimately resulting in death in the 20’s or 30’s.

When Erika F. Augustine, M.D., assistant professor of Neurology and Pediatrics, and in the Center for Human Experimental Therapeutics began caring for patients almost 10 years ago, prospects for Batten disease treatments were limited. Now, Augustine and her colleagues are conducting clinical trials for a therapies that target the root of the disease rather than simply alleviating symptoms.

Below, Augustine, who serves as a member of the Strategic Leadership Group for the CTSI and has utilized the CTSI’s Clinical Research Center to conduct her clinical trials, discusses her research and why she became a doctor and a researcher.

The University of Rochester Medical Center is home to approximately 3,000 individuals who conduct research on everything from cancer and heart disease to Parkinson’s, pandemic influenza, and autism. Spread across many centers, institutes, and labs, our scientists have developed therapies that have improved human health locally, in the region, and across the globe. To learn more, visithttp://www.urmc.rochester.edu/research.

The National Science Foundation has shown that individuals from certain racial and ethnic groups, including Black/African Americans, Hispanics or Latinos, American Indians or Alaska Natives, and Native Hawaiians and other Pacific Islanders are greatly underrepresented in health sciences across the nation. In addition, individuals with physical or mental disabilities or who come from disadvantaged backgrounds experience significant barriers to joining the health science research workforce.

Research Supplements to Promote Diversity in Health-Related Research from the National Institutes of Health are designed to create a pipeline for under-represented individuals to help them overcome those barriers. Investigators with current NIH grants may apply for supplemental funding to recruit or retain under-represented trainees at various stages in their career, from high school students to early career principal investigators.

NIH Diversity Supplements foster the recruitment of the most talented researchers from all backgrounds, which in turn improves our ability to recruit research participants from diverse backgrounds to better address and eliminate health disparities among under-represented populations. Workforce diversity in health research will also improve training environments by inviting a greater range of ideas and balancing perspectives to address research questions and determine research priorities.

In order to apply for the Diversity Supplement, investigators should have at least 2 years remaining on existing NIH grants to support a graduate student or postdoctoral fellow, or at least 1 year remaining for high school, undergraduate, or post-baccalaureate student support.

Diversity Supplements are supported using funds specifically set aside for this purpose and thus can be approved by NIH Project Officers without peer review. This significantly expedites the review process and removes yet another barrier to funding for under-represented individuals.

Many Institutes or Centers accept these applications on a rolling basis, though some may have specific application deadlines. Applicants are strongly urged to consult the following Program Announcement (PA-15-322) for guidance and should contact their program officer prior to submitting an application.

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Ray Dorsey, M.D., David M. Levy professor of Neurology, director of the Center for Human Experimental Therapeutics, and associate director for Clinical Trial Methods and Technologies at the CTSI and URMC, is featured below in a video discussing his research involving a smartphone application that helps assess symptoms of Parkinson’s disease patients from the comfort of their own homes.

Dorsey helped develop the mPower smartphone app, which is a clinical research tool that is helping researchers understand why certain Parkinson’s disease patients experience certain symptoms and how those symptoms change over time. As Dorsey says, the app is not a “one way street of information.” It allows patients to track their own symptoms day to day and provides them with information to help them better manage their symptoms.

One of the most important aspects of this application and clinical research is that breaks down a barrier to research participation and health care access. People can participate in the study and conduct assessments entirely on their phone – without ever having to visit a clinic.

Dorsey’s goal: “Anyone, anywhere in the U.S. can participate in research – regardless of who they are and where they live.”

The University of Rochester Medical Center is home to approximately 3,000 individuals who conduct research on everything from cancer and heart disease to Parkinson’s, pandemic influenza, and autism. Spread across many centers, institutes, and labs, our scientists have developed therapies that have improved human health locally, in the region, and across the globe. To learn more, visithttp://www.urmc.rochester.edu/research.